Abstract
BackgroundClinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth.Methods/designA total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP, Brazil. The participants will be randomly assigned into 2 groups: CT (caries removal with bur and restoration performed with Scotchbond™ Universal Adhesive system associated with Filtek Bulk Fill – 3 M/ESPE) and ART (Caries removal with hand instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix – 3 M/ESPE). Ten untrained dentists will perform the treatment in in dental offices located at public schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operators’ preferences regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect. The significance level for all analyses will be 5 %.DiscussionOur hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART will present superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers.Trial registrationNCT02568917. Registered on May 10th 2015.
Highlights
Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making
Olegário et al BMC Oral Health (2017) 17:34. Currently, both in medicine and dentistry, clinical studies are being conducted in less strict conditions, closer to those found in practice in order to establish an adequate scientific basis for decision making, the so-called pragmatic clinical trials
Few pragmatic studies were conducted in dentistry, especially when the primary outcome is the effectiveness of restorative treatment [2, 3]
Summary
Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth. Both in medicine and dentistry, clinical studies are being conducted in less strict conditions, closer to those found in practice in order to establish an adequate scientific basis for decision making, the so-called pragmatic clinical trials. The fact anesthesia, rubber dam and rotary instruments are not required, stimulated the ART use in the public and private health systems compared to conventional treatment (CT)
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